Is red-yeast rice a safe and effective alternative to statins?

Total adverse events in this study were similar for red-yeast rice and placebo (2.1% vs 1.2%, respectively; P>.05). They included gastrointestinal discomfort, allergic reactions, myalgias, edema, erectile dysfunction, and neuropsychological symptoms.

Red-yeast rice is similar to placebo or another statin in statin-induced myalgia

In patients with known coronary artery disease and dyslipidemia, therapy with red-yeast rice extract is linked to reductions in CHD mortality and myocardial infarction similar to statins. In a small community-based trial of 62 adults with dyslipidemia and a history of statin-induced myalgia, investigators randomized patients to receive either red-yeast rice extract at 1800 mg (with 3.1 mg lovastatin) or placebo twice daily for 24 weeks.⁴ Patients’ weekly self-reports of pain (on a 10-point scale) were skewed at baseline (1.4 in the red-yeast rice group vs 2.6 in the placebo group; P=.026) but similar at 12 weeks (1.4 with red-yeast rice vs 1.9 with placebo; P=.30) and 24 weeks (1.2 with red-yeast rice vs 2.0 with placebo; P=.120).

An RCT of 43 adults with dyslipidemia and history of statin intolerance compared red-yeast rice extract (2400 mg, with 10 mg lovastatin) with pravastatin (20 mg) dosed twice a day.⁵ At the end of 12 weeks, mean self-reported pain scores (on a 10-point scale) were similar (1.4 with red-yeast rice vs 1.1 with pravastatin; P=.82), as were discontinuation rates because of myalgia (5% with red-yeast rice vs 9% with pravastatin; P=.99).

RECOMMENDATIONS

A narrative review of alternative therapies for heart failure and hypercholesterolemia states that red yeast rice may be a cost-saving option for hypercholesterolemia in patients who can’t afford other medications (purchased mostly online, cost $8-$20/month for a dosage equivalent to lovastatin 20 mg/d).⁶

A ConsumerLab review of red yeast rice products available since the FDA ban in 2011 tested products marketed in the United States and found variable amounts of lovastatin.^1,7 The group determined that labeling was a poor guide to lovastatin content, which ranged from 0 to 20 mg per daily dose, and that the products may not have been standardized. The group concluded that therapeutic effects weren’t predictable.